The FDA is warning that taking more than the recommended daily dose of OTC sodium phosphate laxative products to treat constipation can cause rare but serious harm to the kidneys and heart, and even death.
The OTC sodium phosphate products include oral solutions and rectal enemas. They are sold under the brand name Fleet, as well as store brand and generic products. They are available as single-ingredient products or as combination products containing sodium biphosphate and sodium phosphate.
This warning resulted after reports of severe dehydration and electrolyte level abnormalities for calcium, sodium, and phosphate. This led to the harm of organ systems after taking more than the recommended dose in a single dose or taking more than one dose per day.
Healthcare professionals and consumers are to use OTC products as recommended on the Drug Facts label, and to not exceed the labeled dose.
The oral sodium phosphate products should not be used in children <5 years without consulting their healthcare provider and the rectal form should never be given to children <2 years.
Populations that are at increased risk for potential adverse events include young children; patients >55 years old, patients who are dehydrated, patients with kidney disease, bowel obstruction, or inflammation of the bowel, and patients who are using medications that may affect kidney function.
For more information call (800) 332-1088 or visit the FDA Safety Alert page.